BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMA ACCEL

    MDR report key: 3981843 · Received August 5, 2014

    Report

    Report Number
    1722028-2014-00294
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK970005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE TERUMO BCT SERVICE TECHNICIAN CHECKED THE TRIMA MACHINE AT THE CUSTOMER SITE. NO FAULTS WERE DETECTED DURING CHECK-OUT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: COMPLETE PROCEDURAL DETAILS ARE WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. PER THE THERAPEUTIC APHERESIS HANDBOOK: A PHYSICIAN'S REFERENCE, 2ND EDITION, FIRST TIME PROCEDURE PATIENTS REACTIONS MAY OCCUR IN APPROXIMATELY 4.8% OF PROCEDURES, AND 1.2% OF PROCEDURE PATIENTS EXPERIENCE REACTIONS TO CITRATE, BASED ON THE RESULTS OF A SURVEY OF THERAPEUTIC PROCEDURES. OF THESE REACTIONS, MOST WERE MILD AND WELL TOLERATED. THE TRIMA ACCEL SYSTEM HAS MANY SAFETY FEATURES. HOWEVER A DONOR REACTION CAN OCCUR RAPIDLY. THEREFORE, IT IS IMPERATIVE THAT THE TRIMA ACCEL SYSTEM AND THE DONOR BE MONITORED THROUGHOUT THE PROCEDURE. DONORS WITH IMPAIRED OR ABNORMAL CITRATE AND/OR CALCIUM METABOLISM (FOR EXAMPLE, LIVER AND RENAL DISEASES) MAY PRESENT AN INCREASED RISK OF CITRATE SENSITIVITY. FOR THIS REASON, THE ATTENDING PHYSICIAN SHOULD ASSESS THE APPROPRIATENESS OF SUCH DONORS FOR AUTOMATED COLLECTIONS AND PRESCRIBE HOW THEY SHOULD BE MONITORED DURING THE PROCEDURE. (TRIMA ACCEL AUTOMATED BLOOD COLLECTIONS SYSTEM, PAGE XXII)ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. BASED ON THE INFORMATION AVAILABLE, IT IS POSSIBLE THAT THE PATIENT EXHIBITED AN ALLERGIC REACTION TO ACD-A AND/OR ETO, DUE TO THEIR CURRENT PHYSIOLOGICAL CONDITION.

    Description of Event or Problem · 1

    NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DONOR DEVELOPED A REACTION TO THE ANTICOAGULANT DURING A PLATELET COLLECTION PROCEDURE. IT IS NOT KNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458395 TRIMA ACCEL TRIMA ACCEL LRS, PLT, PLS, RBC, AUTOPAS SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other